NCT03258814

A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA)

Treat and Train - A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study is a non-interventional, longitudinal and non-confirmatory study to compare an active supervised training (AST) with standard of care (SOC) physiotherapy in patients with axial spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to health-related outcomes. The primary objective is the improvement in spinal mobility after a 6 month training program.

Detailed description

Treatment of axSpA patients with adalimumab (HUMIRA®) was according to the local adalimumab product label and local standard of care. AxSpA patients who responded to newly initialized adalimumab treatment based on physicians' decision, and who were eligible for active physiotherapy were enrolled in the study. Although this was a non-interventional study, participants were randomly assigned to receive either active supervised and standardized training physiotherapy or standard of care physiotherapy in order to provide adequate numbers of participants in each comparison group. Participants who consented to participate in the study were observed for up to 12 months from Baseline (defined as the Randomization visit where participants were assigned to one of the two physiotherapy options).

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
BEHAVIORAL	Active Supervised Training (AST)	The active supervised and standardized training consisted of 24 units of exercise within 20 weeks performed in certified training centers and was focused on back fitness, core strengthening and patient engagement to treat back pain and functional impairment.
BEHAVIORAL	Standard of Care (SOC) Physiotherapy	Standard of care physiotherapy as used in this study included active as well as passive training and massages according to the physiotherapist discretion.

Timeline

• Start date: 2017-12-08
• Primary completion: 2018-09-14
• Completion: 2018-09-14
• First posted: 2017-08-23
• Last updated: 2019-10-02
• Results posted: 2019-10-02

Locations

6 sites across 1 country: Germany